Biological evaluation of Evolvecomp™ composite materials (GF40PLD96, GF40PLD85, GF40PLG85)

Evolvecomp composite materials were tested for cytotoxicity, irritation or intracutaneous reactivity, sensitization, acute systemic toxicity, and genotoxicity (medical device
composed of Evolvecomp composite materials). An implantation study included the endpoints of material-mediated pyrogenicity, and systemic toxicity
(subacute/chronic).

Biocompatibility study for bioresorbable natural mineral fiber composites long-term effects

Animal Study
Rabbit study

26 weeks results

Materials
injection molded and continuous natural mineral fiber pin with standard negative control article (HD-PE)

No difference in histology between the test articles and the negative control.

4 weeks micro-CT

cortex already closing

13 weeks micro-CT

bone growing around the implants

Biocompatibility study for bioresorbable natural mineral fiber composites long-term effects

Animal Study
Dog study

52 weeks results

Materials
continuous natural mineral fiber pin with reference pin without natural mineral fibers

Natural mineral fiber composite at 6 weeks (A) and 12 weeks (B)

NB: new bone; FM: fibrous tissue; Os: osseointegration

Osseointegration and no fibrous capsule from 12 weeks ->

 

Significantly improved bone growth around natural mineral fiber composite.

Significantly improved bone growth

Biocompatibility test for Evolvecomp™ composite materials. Testing conducted by NAMSA and Eurofins

Biological Evaluation
Degradation, Cytotoxicity, Chemical Characterization, Classification of Plastics, Delayed Sensitivity, Animal/Implantation
Materials
  • Evolvecomp™ GF40PLD96
  • Evolvecomp™ GF40PLD85
  • Evolvecomp™ GF40PLG85
  • X3 fiber

Evolvecomp™  material tested in the customer’s product biocompatibility tests

Biological Evaluation
Cytotoxicity, Irritation, Sensitization, Toxicity, Genotoxicity, Implantation, Chronic toxicity, Carcinogenity, Material-mediated pyrogenicity, Degradation
Materials
Customer´s own implants made from Evolvecomp™  biomaterial
Biocompatibility test for Evolvecomp™ composite materials Testing conducted by NAMSA and Eurofins